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NCT Number: NCT06662669

YL-13027 and/or HY-0102 Combined With AG Regimen Chemotherapy for Metastatic Pancreatic Cancer

In Phase 1b study, six subjects will be enrolled in Arm A (YL-13027 + AG regimen) and Arm B (HY-0102 + AG regimen). The first 12 subjects will be evaluated for safety after one cycle. After safety assessment, subjects will start to enroll in Arm C (YL-13027 + HY-0102 + AG regimen). Each group is planned to include 12-20 subjects. According to the safety and efficacy results of 3 arms of subjects in phase Ib, 1-2 groups were selected for expansion, and a randomized controlled study will be conducted with the standard treatment AG （Arm 4）regimen chemotherapy.

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Key information

Conditions

Metastatic Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject aged between 18 and 75 years.
  • Subject has histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
  • Subject has at least one evaluable metastatic lesion according to RECIST 1.1 criteria;
  • Subject has an ECOG score of 0-1 and is expected to survive more than 3 months;
  • Subjects have a good level of organ function.

Exclusion criteria

  • Subject suitable for potentially curative surgery.
  • The subject confirmed by tissue or cytology as other pathological types, such as acinar cell carcinoma, neuroendocrine carcinoma, etc.
  • The subject has previously received gemcitabine and nab-paclitaxel combination therapy within 6 months of progression or intolerance.

Treatment and study plan

YL-13027

Drug

YL-13027 is a small molecule inhibitor of the TGF-βRI target.

Other names: YL-13027 tablet

HY-0102

Drug

HY-0102 is a recombinant anti-NKG2A humanized monoclonal antibody.

Other names: HY-0102 injection

Gemcitabine

Drug

Gemcitabine is a pyrimidine antineoplastic chemotherapeutic agent.

Other names: Gemcitabine Hydrochloride for Injection

Nab-paclitaxel

Drug

Paclitaxel for Injection (albumin bound) is a chemotherapeutic agent that acts as an antitumor agent by inhibiting tumor cell mitosis

Other names: Paclitaxel for Injection (albumin bound)

Primary outcomes

  1. Objective response rate

    Time frame: From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.

    The proportion of subjects who have a complete response or partial response.

  2. Progression-free survival

    Time frame: From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.

    Progression-free survival is defined clinically as the time from randomization to disease progression or death from any cause

Secondary outcomes

  1. Disease control rate

    Time frame: From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.

    The proportion of subjects who have a complete response, partial response and stable disease.

  2. Adverse events

    Time frame: From time of first dose to 30 days after the last dose.

    Incidence of adverse events evaluated by NCI CTCAE v5.0

  3. Plasma concentration of YL-13027 and HY-0102

    Time frame: From one hour before the first dose to the last dose up to 24months.

    This composite endpoint will measure the plasma concentration of YL-13027 and HY-0102.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhingqiang Wang

CONTACT

[email protected]

020-87343571

Sponsors and collaborators

Lead sponsor

Shanghai YingLi Pharmaceutical Co. Ltd.

Industry

Registry information

Official study title

A Randomized, Open, Parallel-controlled, Multi-center , Phase Ib/Ⅱ Clinical Trial of YL-13027 and/or HY-0102 Combined With AG（Nab-paclitaxel and Gemcitabine) Regimen Chemotherapy for Metastatic Pancreatic Cancer

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Oct 29, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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